Conformity Assessment And Risk Management Under .
Conformity Assessment and Risk Managementunder Consideration of Applicable HarmonizedStandardsDipl.-Ing. Sven Wittorf, M.Sc.Lübeck, 2013-09-12
Declaration of Conformity
Conformity Assessment ProceduresAnnex VIIAnnex IIIAnnex IIECdeclaration ofconformityEC type-examinationfull qualityassurancesystemAnnex IVAnnex VAnnex ualityassurancexxxx
Manufacture DesignConformity Assessment ProceduresAnnex VIIAnnex IIIAnnex IIECdeclaration ofconformityEC type-examinationfull qualityassurancesystemAnnex IVAnnex VAnnex ualityassurancexxxx
Conformity Assessment ProceduresAnnex VIIAnnex IIIAnnex IIECdeclaration ofconformityEC type-examinationfull qualityassurancesystemAnnex IVAnnex VAnnex VIECverificationnot ynot reassurancecommendedxxxxAccording to NB-MED/2.2/Rec4
Conformity Assessment ProceduresAnnex VIIAnnex IIIAnnex IIECdeclaration ofconformityEC type-examinationfull qualityassurancesystemHardlyAnnex IV applicableAnnex V Annex softwareassuranceassurancexxxx
Conformity Assessment ProceduresAnnex IIECdeclaration ofconformityEC type-examinationfull qualityassurancesystemAnnex IVAnnex VAnnex ualityassurancexxxxall the rest Annex IIIClass IAnnex VII
Annex IX – Classification of SoftwareStand alone software is considered to bean active medical device.MDD Annex IX – Definition 1.4
Annex IX – Classification of SoftwareActive devices intended for diagnosis are inClass IIa [ ] if they are intended to allow directdiagnosis or monitoring of vital physiologicalprocesses [ ]MDD Annex IX – Rule 10
Annex IX – Classification of SoftwareActive devices [ ] specifically intended formonitoring of vital physiological parameters,where the nature of variations is such that itcould result in immediate danger to the patient[ ], are in Class IIbMDD Annex IX – Rule 10
Annex IX – Classification of SoftwareAll other active devices are in Class I.MDD Annex IX – Rule 12
Annex IX – Classification of SoftwarenoOther rules apply(e.g. rule 9)?Class accordingto other rule(s)yesyesdirect diagnosis ormonitoring of vitalphysiological processes?variations of parameterscould result in immediatedanger?yesClass IClass IIaClass IIb
Guideline on ClassificationMEDDEV 2.1/6 – Classification of Standalone Software
Essential RequirementsThe devices must meet the essentialrequirements set out in Annex I whichapply to them, taking account of theintended purpose of the devicesconcerned.MDD Article 3 – Essential requirements
Essential RequirementsThe devices must be designed andmanufactured in such a way that [ ] theywill not compromise [ ] the safety ofpatients [ ]MDD Annex I – Essential Requirement #1
What is „Safety“?Safety:freedom from unacceptable riskISO/IEC Guide 51:1999, definition 3.1, cited in ISO 14971:2012
Essential RequirementsRequirementsTestsThe devices must achieve theperformances intended by themanufacturer [ ]MDD Annex I – Essential Requirement #3
Essential RequirementsFor devices which [.] are medical softwarein themselves, the software must bevalidated according to the state of the arttaking into account the principles ofdevelopment lifecycle, risk management,[ ].MDD Annex I – Essential Requirement #12.1a
Essential RequirementsRequirementsTestsFor devices which [.] are medical softwarein themselves, the software must bevalidated according to the stateof the artIntegrationArchitectureTeststaking into account the principlesofdevelopment lifecycle, risk management,[ ].Module TestsDesignImplementationMDD Annex I – Essential Requirement #12.1a
Long long before Konrad Zuse
Risk Management1 Identify risks2 Estimate and assessrisks3 Control risks
Quality Management1 Plan things2 Do things3 Check if things have beendone according to the plan
Medical Software?
Harmonized StandardsMember States shall presumecompliance with the essentialrequirements [.] in respect of deviceswhich are in conformity with [.]harmonized standards [.]MDD Article 5 – Reference to standards
Harmonized Standard
Harmonized (Process) StandardsMedical Device Directive 93/42/EECrequiresrequiresrequiresrequiresSW sabilityEN ISO 14971EN 62366requiresrequiresEN 62304EN ISO 13485requiresrequires
Technical DocumentationThe technical documentation must allowassessment of the conformity of the productwith the requirements of the Directive.MDD Annex VII – EC Declaration of Conformity
Technical Documentation39
RecommendationNB-MED/2.5.1/Rec5 – Technical Documentation
Summary: Medical Software
Any questions?sven.wittorf@johner-institut.de43
According to NB-MED/2.2/Rec4. Conformity Assessment Procedures Annex III EC type-examination Annex IV EC verification Annex V production quality assurance Annex VI product quality assurance Annex VII EC declaration of conformity Annex II full quality assurance system xxxx Hardly
1. There is a toolbox of conformity assessment approaches intended to meet a range of needs. 2. Conformity assessment program models vary based on balancing risk and resources. 3. Software and cybersecurity bring challenges to conformity assessment. Certain commercial products, organizations and websites are identified.
The online survey was distributed to stakeholders throughout the conformance system, and they completed the survey between 26 June and 10 July 2018. The target survey sample were organisations which provide conformity assessments (ie conformity assessment bodies) and organisations which use conformity assessment services. The aim was to hear from
8. conformity assessment bodies Bodies that perform conformity assessment activities, including testing, calibration, certification and inspection. 9. Designation Acceptance of the applicant body that applicate to perform conformity assessment services in specific field in accordance with the rules of this procedure. 10. Applicant bodies
Risk is the effect of uncertainty on objectives (e.g. the objectives of an event). Risk management Risk management is the process of identifying hazards and controlling risks. The risk management process involves four main steps: 1. risk assessment; 2. risk control and risk rating; 3. risk transfer; and 4. risk review. Risk assessment
Tunnelling Risk Assessment 0. Abstract 1. Introduction and scope 2. Use of risk management 3. Objectives of risk assessment 4. Risk management in early design stages 5. Risk management during tendering and contract negotiation 6. Risk management during construction 7. Typical components of risk management 8. Risk management tools 9. References .
AWS Conformity Assessment Report for: Coca Cola HBC Hrvatska d.o.o. LR reference: PIR0361689/ 3216964 AWS reference number: AWS-000317 Assessment dates: 10-11/12/2020 Assessment location: 1 Milana Sachsa, Zagreb 10000, Croatia Assessment criteria: AWS Standard Version 2, 22/03/2019 Assessment team: Artemis Papadopoulou Assessment type: Initial assessment
NIST SP 800-30: Risk Management 5 NIST SP 800-30: Risk Management Risk management encompasses three processes Risk Assessment Risk Mitigation Evaluation and Assessment **005 Within this document, there . are the three processes. There's risk . assessment, risk mitigation, and . evaluation an
81. Risk Identification, page 29 82. Risk Indicator*, page 30 83. Risk Management Ω, pages 30 84. Risk Management Alternatives Development, page 30 85. Risk Management Cycle, page 30 86. Risk Management Methodology Ω, page 30 87. Risk Management Plan, page 30 88. Risk Management Strategy, pages 31 89. Risk
